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NCT Number: NCT06162624

Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons

The goal of this research study is to adapt an ACT-self-help workbook to the prison setting and determine the feasibility acceptability, and effectiveness of this workbook.

Participants can expect to be in the study for 13 weeks.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location status: Recruiting

About this study

The Specific Aims of the proposed study correspond directly to the three-step process.

  • In Step 1 (Specific Aim #1), identify the necessary adaptations to the content, language, and format of an ACT-based self-help workbook through stakeholder input.
  • In Step 2 (Specific Aim #2), refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook.
  • In Step 3 (Specific Aim #3), determine the feasibility, acceptability and preliminary effectiveness of the ACT self-help workbook in a prison setting. Primary clinical outcome measure will be depression, secondary clinical outcome measure will be anxiety.

For each participant assigned to a condition, a study team member will meet with them individually to provide them with a copy of the workbook. During this meeting, the study team member will inform the participant that they should complete one chapter per week.

Participants will complete a Pre-Treatment Assessment prior to distribution of the workbook; a Mid-Treatment Assessment four weeks after the distribution of the workbook; a Post-Treatment Assessment #1 eight weeks after distribution of the workbook (when the workbook should be completed); Focus group (after completion of workbook) and, a Post-Treatment Assessment #2 twelve weeks after distribution of the workbook.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Reading level of 6th grade or higher determined by the Wide Range Achievement Test
  • Moderate or severe anxiety and/or depression determined by the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI)
  • No active self-harm or active suicidal intent
  • No scheduled transfer or release for at least three months
  • Must be willing and able to participate, including having permission and ability to use study materials, such as paper and a writing utensil

Exclusion criteria

  • Unable to provide informed consent
  • Active self-harm or suicidal intent
  • Scheduled transfer or release within three months

Treatment and study plan

Acceptance and Commitment Therapy (ACT)

Behavioral

ACT: Therapy that builds in traditional cognitive behavioral therapy principles but emphasizes different processes in behavior change. Delivered over 8 weeks of self-guided study and homework assignments.

Reflective Journaling

Behavioral

As control condition, reflective journaling will be used.

Primary outcomes

  1. Eligible participants

    Time frame: Study duration, up to 1 year

    Feasibility will be assessed by measuring eligibility - percentage of individuals who meet inclusion criteria versus percentage of individuals who are excluded.

  2. Participants who choose to participate

    Time frame: Study duration, up to 1 year

    Feasibility will be assessed by measuring the percentage of eligible individuals who choose to participate in the study.

  3. Percentage of participants that complete all 8 weeks

    Time frame: Study duration, up to 1 year

    Feasibility will be assessed by measuring the percentage of participants who complete all treatment activities

  4. Qualitative Summary of Reasons for Attrition

    Time frame: Study duration, up to 1 year

    Feasibility will be assessed qualitatively by asking participants who leave the study, why they decided to stop. Responses will be coded for themes and summarized with participant counts.

  5. Number of Participants referred for Follow up care

    Time frame: Up to 13 weeks

    Safety will be measured through participant self-report suicidal or self-harm ideation, using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a questionnaire designed to assess the level of risk for self-harm. Any participant that indicates active suicidal ideation with intent to act or active suicidal ideation with a specific plan on the C-SSRS will be referred for follow up care.

  6. Participant Satisfaction

    Time frame: Up to 13 weeks

    Acceptability of the method will be assessed through Client Satisfaction Questionnaire (CSQ-8), which is an 8 item survey with potential scores of 8-32 with higher scores indicating greater satisfaction.

  7. Change in Mental Health: Flexibility

    Time frame: Baseline to 13 weeks

    The Multidimensional Psychological Flexibility Inventory (MPFI) assesses the 12 dimensions of flexibility and inflexibility. Responses have point values from 1 to 6, where higher scores reflect higher levels of the dimension being assessed by each set of items.

  8. Change in Mental Health: Automatic Thoughts

    Time frame: Baseline to 13 weeks

    The Automatic Thoughts Questionnaire lists are a variety of thoughts that pop into people's heads. Participants read each thought and indicate how frequently, if at all, the thought has occurred over the past week. 30 questions with a scale of 1-5, with 1 = not at all and 5 = all of the time. Higher scores indicate higher frequency of automatic thoughts.

  9. Change in BAI Score

    Time frame: Baseline to 13 weeks

    Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".

  10. Change BDI-II Score

    Time frame: Baseline to 13 weeks

    Beck Depression Inventory (BDI-II) Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Madilyn Michels

CONTACT

[email protected]

920-602-5612

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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